Devices and methods for treating an artery

ABSTRACT

A method for treating tissue of at least one of an internal carotid artery, an ophthalmic artery, or an ostium between the internal carotid artery and the ophthalmic artery of a subject may include expanding a first expandable device of a first device in the internal carotid artery. The method also may include delivering a second device in the ophthalmic artery via the first device and expanding a second expandable device of the second device in the ophthalmic artery. Further, the method may include adjusting a radial position of the second expandable device relative to the first expandable device.

I. CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation-in-part application of InternationalApplication No. PCT/US2018/031229, filed on May 4, 2018, and claims thebenefit under 35 U.S.C § 119(e) of U.S. Provisional Application No.62/502,733, filed May 7, 2017, U.S. Provisional Application No.62/513,383, filed May 31, 2017, and U.S. Provisional Application No.62/523,724, filed Jun. 22, 2017, the entirety of each of which isincorporated by reference herein.

II. FIELD

The present disclosure relates to medical devices, systems and relatedmethods for removal and/or treatment of one or more of a blockage,lesion, or other tissue in a small diameter artery, such as theophthalmic artery. Additionally, the present disclosure relates tomedical devices, systems, and related methods of improving or restoringblood flow in such an artery, and/or to treating an eye disease orcondition.

III. BACKGROUND

Diseases of the eye, specifically age-related macular degeneration(AMD), glaucoma, and diabetic retinopathy affect a large percentage ofthe population. In part, most of the diseases of the eye are treated bytreating one or more symptoms, but failing to address the underlyingcause(s) of the disease or condition. These therapies are thereforedeficient in one or more aspects, necessitating improved approaches.

In a general sense, the pathogenesis of some eye diseases is similar ifnot the same as those seen for cardiac diseases and for abdominal aortaconditions. However, the anatomy of the vasculature behind the eye istypically smaller, includes more branches, and includes more sharpangles in the blood flow pathway. Further, the vascular system supplyingblood to the eye is closer to the brain and any uncaptured ornon-rerouted debris may, upon reaching the brain, cause an immediatestroke.

The use of catheter delivery systems for positioning and deployingtherapeutic devices, such as balloons, stents and embolic devices, inthe vasculature of the human body has become a standard procedure fortreating endovascular diseases. It has been found that such devices areparticularly useful as an alternative in treating areas wheretraditional operational procedures are impossible or pose a great riskto the patient. Some of the advantages of catheter delivery systems arethat they provide methods for treating blood vessels by an approach thathas been found to reduce the risk of trauma to the surrounding tissue,and they also allow for treatment of blood vessels that in the pastwould have been considered inoperable.

Obstructive emboli have also been mechanically removed from varioussites in the vasculature for years. For example, an embolectomy cathetersuch as, for example, a “Fogarty catheter,” or variations thereof, hasbeen used to remove clots from arteries found in legs and in arms. Thesewell-known devices are described, for example, in U.S. Pat. No.3,435,826 to Fogarty, and in U.S. Pat. Nos. 4,403,612 and 3,367,101. Ingeneral, these patents describe a balloon catheter in which a balloonmaterial is longitudinally stretched when deflated.

In procedures for removing emboli using such embolectomy catheters orother similar catheters, it is typical to first locate the clot usingfluoroscopy. Next, the embolectomy catheter is inserted and directed tothe clot. The distal tip of the catheter is then carefully moved throughthe center of the clot. Once the balloon has passed through the distalside of the clot, the balloon is inflated. The catheter is thengradually, proximally withdrawn. The balloon, in this way, acts to pullthe clot proximally ahead of the balloon to a point where it can beretrieved. The majority of procedures using a Fogarty-type catheterrepeat these steps until the treated vessel is cleared of clot material.

A variety of alternative emboli retrieval catheters have also beendeveloped, in which various wire corkscrews and baskets must be advanceddistally through the embolic material in order to achieve capture andremoval. However, removal of emboli using such catheters may give riseto potential problems. One such problem may occur when advancing thecatheter through the clot dislodges material to a more remote site whereremoval may become more difficult or impossible.

The terms proximal and distal, as used herein, refer to a direction or aposition along a longitudinal axis of a catheter or medical instrument.Proximal refers to the end of the catheter or medical instrument closerto the operator, while distal refers to the end of the catheter ormedical instrument closer to the patient.

The measurement term French, abbreviated Fr or F, is defined as threetimes the diameter of a device as measured in mm. Thus, a 3 mm diametercatheter is 9 French in diameter.

There are various terms for the parts of the anatomy from the internalcarotid artery (ICA) through the ophthalmic artery (OA) to the eye.Hayreh et al. (Brit. J. Ophthal., 46, 65 (1962)), incorporated byreference in its entirety herein, particularly FIG. 4, illustrates theICA and the OA. Specifically, the OA branches off the ICA in a portioncalled the “short limb.” An “angle a” is a distinctive turn in the OAnear an end of the short limb, and the “long limb” is the portion of theOA before it penetrates into the dural sheath. One skilled in the artwill readily recognize that while these are typical or commonstructures, not all subjects/patients/humans have these exact samestructures, e.g., there are human population variations.

IV. SUMMARY

The present disclosure is directed to one or more intravascular medicaldevices and methods intended to sufficiently unblock or at leastpartially restore blood flow in a blocked or partially blocked arterysuch that nutrient(s) content is increased distal to the blockage. Anembodiment of the present disclosure is directed to devices and methodsfor restoring blood flow through the ostium between an internal carotidartery (ICA) and an ophthalmic artery (OA) of a subject. An embodimentof the present disclosure includes using these devices and methods torestore or increase blood flow to the eye or a portion thereof. Anembodiment of the present disclosure includes restoring or increasingnutrient levels in the eye or a portion thereof. Restoring or increasingblood flow may include using these devices and methods, or equivalentdevices and methods, but is not to be limited thereby.

As used herein, blockage, occlusion, or obstruction refers to completeor partial blockage resulting in reduced, restricted, or eliminatedblood flow and is sometimes caused by plaque or other tissue, tortuousshaped anatomy, vessel failure and/or dysfunction.

The Circle of Willis, as used herein, refers to interconnected cranialarteries between branches of the internal carotid arteries and thevertebral arteries at the base of the brain.

Superior (or cranial), as used herein, refers to a location above ahorizontal plane extending through an identified anatomical structure.Inferior (or caudal), as used herein, refers to a location below ahorizontal plane extending through an identified anatomical structure.For example, at least a portion of the Circle of Willis is superior tothe ophthalmic artery.

While not intending to be restricted to any particular theory ofoperation, function, or causal connection, it is believed that acondition, such as a blockage, that leads to lowered nutrientavailability and/or consumption contributes to abnormal physiologicfunction. Also, it is believed that those conditions may reducemetabolic waste removal from cells, organs, and other biologicalstructures.

Possible such conditions include but are not limited to one or more ofthe following: reduced or blocked blood flow in one or more arteries orsystem of arteries; reduced or blocked source of energy or nutrients toa cell, organelle of a cell, mitochondrion, group of cells, or organ;altered aerobic energy metabolism; altered mitochondria oxidativephosphorylation; decreased or blocked supply of glucose; decreasedhemoglobin amount or delivery to one or more intra-cranial structures orto one or more eye tissues; reduced blood flow or rate anywhere in thefluid flow path between the ICA and eye tissue; blockage or partialblockage in one or more arteries or system of arteries; any compromiseof the complement system, the complement cascade, and/or one of thecomplement cascade associated molecules; and lowered/blocked nutrientsupply and/or metabolic waste removal.

These conditions may occur in one or more of the following areas orstructures: one or more arteries; one or more cranial arteries; and oneor more arteries associated with of supplying blood flow to the eye; theICA; the OA; anywhere in the fluid flow path between the ICA and eyetissue; the junction between the ICA and the OA, which is referred to inthis disclosure as the ostium; and secondary areas of the anatomyincluding the vascular system (commonly referred to as the terminalbranches). These secondary areas include, but are not limited to thesupra orbital artery (SOA), the supra trochlear artery (STA), the dorsalnasal artery (DNA), and the facial arteries (FA); any cranial artery;and in any of the junctions or ostia between any of the vasculaturebetween the ICA and one or more eye tissues.

Examples of diseases and conditions that can occur in these bloodvessels, and which may be treated by systems and methods describedherein, may include, but are not limited to, any of a variety of eyediseases, including but not limited to AMD (both dry and wet); neuronalcell death; Alzheimer's disease; dementia; glaucoma; diabetic maculaedema, macular telangiectasia (e.g., type 1 or 2 maculartelangiectasia), atrophic macular degeneration, chorioretinopathy (e.g.,central serous chorioretinopathy), retinal inflammatory vasculopathy,pathological retinal angiogenesis, age-related maculopathy,retinoblastoma, pseudoxanthoma elasticum, vitreoretinal disease,choroidal sub-retinal neovascularization, central serouschorioretinopathy, ischemic retinopathy, hypertensive retinopathy ordiabetic retinopathy (e.g., nonproliferative or proliferative diabeticretinopathy, such as macular edema or macular ischemia), retinopathy ofprematurity (e.g., associated with abnormal growth of blood vessels inthe vascular bed supporting the developing retina), venous occlusivedisease (e.g., a retinal vein occlusion, branch retinal vein occlusionor central retinal vein occlusion), arterial occlusive disease (e.g.,branch retinal artery occlusion (BRAO), central retinal artery occlusionor ocular ischemic syndrome), central serous chorioretinopathy (CSC),cystoid macular edema (CME) (e.g., affecting the central retina ormacula, or after cataract surgery), retinal telangiectasia (e.g.,characterized by dilation and tortuosity of retinal vessels andformation of multiple aneurysms, idiopathic JXT, Leber's miliaryaneurysms, or Coats' disease), arterial macroaneurysm, retinalangiomatosis, radiation-induced retinopathy (RIRP), or rubeosis iridis(e.g., associated with the formation of neovascular glaucoma, diabeticretinopathy, central retinal vein occlusion, ocular ischemic syndrome,or chronic retinal detachment); distortions and/or blind spots(scotoma); changes in dark adaptation (diagnostic of rod cell health);changes in color interpretation (diagnostic of cone cell health);decrease in visual acuity; and cataract (e.g., age-related cataract).

Methods and devices are also described in this disclosure for OAinterventional procedures, such as stenting, angioplasty, andatherectomy, performed through a transcervical or transfemoral approachinto the OA, either using an open surgical technique or using apercutaneous technique, such as a modified Seldinger technique. Some ofthese methods and devices are particularly useful in procedures whichuse reverse or retrograde flow protocols (e.g., such as those thatimpede, block, or otherwise stop antegrade blood flow).

The disclosed methods and devices include arterial access sheaths,closure devices, and/or interventional catheters. The methods anddevices described herein are useful for procedures utilizing any methodof embolic protection, including distal filters, flow occlusion,retrograde flow, or combinations of these methods, or for procedureswhich do not use any method of embolic protection. Specific methods anddevices for embolic protection are also described.

The present disclosure provides a system useable for performing atherapeutic and/or diagnostic task at a location within the body of ahuman or animal subject. Such a system may include a catheter that has aproximal portion, a distal portion, a lumen and a distal end opening.The catheter may be transitionable from a first configuration in whichthe distal portion has a first outer diameter that is smaller than anouter diameter of the proximal portion, and a second configuration inwhich the distal portion is expanded to a second outer diameter that islarger than the first outer diameter and, in some embodiments, no largerthan the outer diameter of the proximal portion. The described systemmay further include a working device that can be advanced though thelumen of the catheter and out of the distal opening of the catheter atleast when the distal portion of the catheter is in is secondconfiguration. The working device may be useable to perform atherapeutic or diagnostic task. Examples of the types of working devicesthat may be used in this system include, but are but are not limited to,(i) devices for removing thrombus or other obstructive matter from bodylumens, (ii) flow restoration devices useable to facilitate flow of afluid though or around an obstruction within a body lumen, and (iii)devices for deploying or delivering implants (e.g., implantableocclusion coils or implantable embolic devices).

Further in accordance with the present disclosure, there is provided amethod for performing a therapeutic or diagnostic task at a locationwithin the body of a human or animal subject. Such a method may includeinserting into the subject's body a catheter that has a proximalportion, a distal portion, a lumen, and a distal end opening. Thecatheter may be transitionable from a first configuration in which thedistal portion has a first outer diameter that is smaller than an outerdiameter of the proximal portion and a second configuration in which thedistal portion is expanded to a second outer diameter that is largerthan the first outer diameter and, in some embodiments, no larger thanthe outer diameter of the proximal portion. The method may furtherinclude positioning the distal end opening of the catheter in a desiredbody lumen while the distal portion of the catheter is in its firstconfiguration. Further, the method may include causing the distalportion of the catheter to transition to the second configuration,advancing a working device though the lumen of the catheter and out ofthe distal opening, and using the working device to perform thetherapeutic or diagnostic task. Examples of the types of working devicesthat may be used in this method include, but are but are not limited to,devices for removing thrombus or other obstructive matter from bodylumens, flow restoration devices useable to restore blood flow throughan obstructed body lumen, and devices for delivering implants (e.g.,implantable occlusion coils or embolic devices).

In a further aspect, there is provided a method for removing obstructivematter from a body lumen. Such a method may include inserting a catheterthat has a proximal portion, a distal portion, a lumen and a distal endopening into the body of a subject. The catheter may be transitionablefrom a first configuration in which the distal portion has a first outerdiameter that is smaller than an outer diameter of the proximal portionand a second configuration in which the distal portion is expanded to asecond outer diameter that is larger than the first outer diameter and,in some embodiments, no larger than the outer diameter of the proximalportion. The method may further include positioning the catheter, whilein the first configuration, such that its distal end opening of thecatheter is within a body lumen of the subject, causing the catheter totransition from the first configuration to the second configuration,moving obstructive matter through the distal end opening and into thelumen of the catheter, and removing the catheter along with theobstructive matter that has been moved into the lumen of the catheter.In some embodiments, negative pressure may be applied through the lumenof the catheter to aspirate obstructive matter through the distal endopening and into the lumen of the catheter.

In some embodiments, advancing a working device through a lumen of thecatheter or moving obstructive matter through the distal opening of thecatheter may include advancing an obstructive matter moving device(e.g., an embolectomy device) from the catheter and using theobstructive matter moving device to move obstructive matter through thedistal end opening and into the lumen of the catheter. One non-limitingexample of the types of obstructive matter moving devices that may beused is a device having an expandable element that is expanded withinthe body lumen such that obstructive matter becomes entrained in orengaged by the expandable element in a manner that allows it tothereafter move some or all of the obstructive matter. Such anexpandable element may then be retracted, along with obstructive matterthat has become entrained in or engaged by the expandable member,through the distal end opening and into the lumen of the catheter. Insome examples, the method may further include delivering a therapeuticsubstance. For example, in cases where the obstructive matter comprisesthrombus, a thrombolytic agent or other substance that may dissolve someof a thrombus and/or deter adherence of the thrombus to a wall of thebody lumen may be delivered. In some embodiments where an obstructivematter moving device is used, such obstructive matter moving device maybe initially used to canalize or compress the obstructive matter in amanner that improves blood flow through or around the obstructive matterfor a period of time and, thereafter, is used to move at least some ofthe obstructive matter through the distal opening and into the lumen ofthe catheter.

Still further in accordance with the present disclosure, a method forincreasing flow of a body fluid (e.g., blood) through an obstructed bodylumen is described. Such a method may include inserting a catheter thathas a proximal portion, a distal portion, a lumen, and a distal endopening into a body of a subject. The catheter may be transitionablefrom a first configuration in which the distal portion has a first outerdiameter that is smaller than an outer diameter of the proximal portionand a second configuration in which the distal portion is expanded to asecond outer diameter that is larger than the first outer diameter and,in some embodiments, no larger than the outer diameter of the proximalportion. Additionally, the method may include positioning the catheter,while in the first configuration, such that the distal end opening iswithin a body lumen. Further, the method may include causing thecatheter to transition from the first configuration to the secondconfiguration, and using the catheter to deliver a treatment thatrestores or improving flow of a body fluid (e.g., blood) through anobstructed body lumen. In some embodiments, the treatment delivered maycomprise the delivery of a therapeutic substance (e.g., a thrombolyticagent) of a type and in an amount that is effective to improve flow ofbody fluid through the body lumen. In some embodiments, the treatmentdelivered may comprise use of a device that canalizes or compressesobstructive matter in a manner that improves flow of body fluid throughor around the obstructive matter.

In other embodiments, an expandable guide catheter may be used toperform therapy. The expandable guide catheter can include a side portlocated proximal to an expandable distal region of the catheter. Theside port of the expandable guide catheter may communicate fluidlybetween an environment external to the catheter and an internal lumen ofthe catheter. The expandable guide catheter may include a translationdilator that includes at least one window that can be aligned with theside port on the exterior of the catheter to permit fluid communicationbetween the external environment adjacent the catheter and the internallumen of the catheter. The internal lumen may reside radially inside thetranslation dilator. The expandable guide catheter can further include aremovable obturator or lead guidewire. The expandable guide catheter mayserve as a temporary shunt for the vasculature or other body lumen.

In use, the therapeutic expandable guide catheter may be advanced towardand through an obstruction such as a clot or region of spasm within avessel. The obstruction may be penetrated by the removable obturator orguidewire which may be followed by the radially collapsed distal end ofthe expandable guide catheter. The obturator may be removed once theobstruction is fully penetrated and the distal end of the expandableregion is securely within the unobstructed vessel lumen distal (e.g.,downstream) of the obstruction. The translation dilator may then beadvanced distally to expand the distal, expandable region. Additionally,the window in the side wall of the translation dilator may be alignedwith the port or window in the proximal portion of the expandable guidecatheter. In other embodiments, the obturator can remain within thetranslation dilator while it is being advanced distally to expand thedistal, radially expandable region. Blood flow through the vesselobstruction can be restored in this way since blood can flow into thewindow or port within the sidewall of the expandable guide catheter andflow out through the open distal end of the central lumen of thetranslation dilator. In other embodiments, blood flow can also berestored or improved in the reverse direction.

The present disclosure also generally relates to constructions forintravascular treatment devices useful for removing vascular occlusionmaterial from a vascular occlusion or other tissue or material from avascular lumen. The present disclosure more specifically relates toexpandable intravascular occlusion material removal devices, as well asto methods of using those devices to treat eye diseases and conditions.

Vascular diseases, for example, may take the form of deposits, growths,or other tissue or material in a patient's vasculature which mayrestrict, in the case of a partial occlusion, or stop, in the case of atotal occlusion, antegrade blood flow to a certain portion of thepatient's body.

Further non-invasive, intravascular treatments may exist that are notonly pharmaceutical, but also revascularize blood vessels or lumens bymechanical means. Examples of such intravascular therapies includeballoon angioplasty, atherectomy, and vascular dilator(s), whichphysically revascularize a portion of a patient's vasculature.

Balloon angioplasty may include intravascular insertion of a ballooncatheter into a patient through a relatively small puncture, which maybe located proximate the groin, and intravascularly navigated by atreating physician to the occluded vascular site. The balloon cathetermay include a balloon or dilating member which may be placed adjacentthe vascular occlusion and then inflated. Intravascular inflation of thedilating member by sufficient pressures, on the order of 5 to 12atmospheres or so, may cause the balloon to displace the occludingmatter to revascularize the occluded lumen and thereby restoresubstantially normal blood flow through the revascularized portion ofthe vasculature. It is to be noted, however, that this procedure doesnot remove the occluding matter from the patient's vasculature, butrather, displaces it.

While balloon angioplasty is quite successful in substantiallyrevascularizing many vascular lumens by reforming the occludingmaterial, other occlusions may be difficult to treat with angioplasty.Specifically, some intravascular occlusions may be composed of anirregular, loose, or heavily calcified material which may extendrelatively far along a vessel or may extend adjacent a side branchingvessel, and thus are not prone or susceptible to angioplasty treatment.Even if angioplasty is successful in revascularizing the vessel andsubstantially restoring normal blood flow therethrough, there is achance that the occlusion may recur. Recurrence of an occlusion mayrequire repeated or alternative treatments given at the sameintravascular site.

Accordingly, attempts have been made to develop other alternativemechanical methods of non-invasive or less invasive, intravasculartreatment in an effort to provide another way of revascularizing anoccluded vessel and of restoring blood flow through the relevantvasculature. These alternative treatments may have particular utilitywith certain vascular occlusions, or may provide added benefits to apatient when combined with balloon angioplasty and/or drug therapies.

One such alternative mechanical treatment method involves removal, notdisplacement, as is the case with balloon angioplasty, of the materialoccluding a vascular lumen. Such treatment devices, sometimes referredto as atherectomy devices, use a variety of means, such as lasers,rotating cutters (e.g., blades), or ablaters, for example, to remove theoccluding material. The rotating cutters may be particularly useful inremoving certain vascular occlusions. Since vascular occlusions may havedifferent compositions and morphology or shape, a given removal orcutting element may not be suitable for removal of a certain occlusion.Alternatively, if a patient has multiple occlusions in his vasculature,a given removal element may be suitable for removing only one (or lessthan all) of the occlusions. Suitability of a particular cutting elementmay be determined by, for example, its size or shape. Thus, a treatingphysician may have to use a plurality of different treatment devices toprovide the patient with complete treatment. This type of procedure canbe quite expensive because multiple pieces of equipment may need to beused (such intravascular devices are not reusable because they areinserted directly into the blood stream), and may be tedious to performbecause multiple pieces of equipment must be navigated through anoften-tortuous vascular path to the treatment site.

With the following enabling description of the drawings, the apparatusshould become evident to a person of ordinary skill in the art.

V. BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A illustrates an exemplary catheter of the present disclosureincluding a balloon configured for placement in the OA;

FIG. 1B is a cross-sectional view of the catheter in FIG. 1A taken alongline B-B of FIG. 1A;

FIG. 1C is a side view of the catheter shown in FIG. 1A;

FIG. 1D is cross-sectional view of the catheter in FIG. 1A taken alongline D-D of FIG. 1C;

FIG. 2 illustrates a two-lumen catheter including a balloon attached toa band that stretches when the balloon is inflated and allows theballoon to conform to the anatomy between the ICA and the OA;

FIG. 3 illustrates a three-lumen device and an elongation member thatallows the balloon to conform to the anatomy between the ICA and the OA;

FIG. 4 illustrates a balloon which is offset or inflatable on one sideso as to be asymmetrical;

FIG. 5 illustrates a medical device in which a tip houses both aguidewire and a distal end of a balloon, and where the balloon lumen isflexible at both distal and proximal ends of the balloon;

FIG. 6 illustrates a two-lumen catheter in which one lumen houses aballoon and a guidewire, and a second lumen is a balloon inflationlumen;

FIG. 7 illustrates a device according to the present disclosure in usewithin the ICA and the OA;

FIG. 8 illustrates a two-balloon medical device in which one balloon isadapted to conform to the ostium of the OA;

FIGS. 9 A-D illustrate a balloon device pre-shaped to conform to theostium anatomy;

FIGS. 10 A-C illustrate a two-balloon medical device in which oneballoon is configured for placement in the OA (e.g., a dilation balloon)and an anchoring or support balloon is configured for placement in theICA, and a guiding catheter (FIG. 10C);

FIGS. 11 A-D show a close-up view of a balloon configured for use in theOA;

FIGS. 12 A-D show a variation of a balloon in which different attachmentpoints to the guidewire allow the balloon to conform to the anatomy ofthe junction between the ICA and the OA;

FIGS. 13 A-C illustrate variations of a balloon and method in which theballoon intentionally slides out of the OA, thereby removing a blockagein the OA;

FIGS. 14 A-C illustrate alternative two-balloon configurations in whichFIG. 14A shows a bifurcated first balloon and a second balloon shapedfor placement in the OA;

FIGS. 15A and 15B illustrate alternative designs for a multiple lumendevice;

FIGS. 16A and 16B illustrate a site-specific blockage in the OA;

FIGS. 16C and 16D illustrate alternative designs for removing asite-specific blockage in the OA;

FIG. 17 illustrates an embodiment of the present disclosure having aperfusion balloon;

FIG. 18 is an alternative embodiment of a perfusion system in whichblood may flow through the catheter;

FIG. 19 illustrates an embodiment of a device in which a portion of thedevice is configured for the ophthalmic artery and can be mechanicallyextended or angled to conform to ICA/OA anatomy;

FIG. 20 illustrates the embodiment of FIG. 19 in a closed position;

FIG. 21 illustrates a three-balloon configuration having an anchorballoon and two ophthalmic artery balloons;

FIG. 22 illustrates a two-lumen configuration in which a balloon lumenis deployed in the ICA and enters the OA from the cranial or superiorside; and

FIG. 23 illustrates the delivery of a medical device toward the OA via aportion of the Circle of Willis.

VI. DETAILED DESCRIPTION

In at least certain embodiments, the present disclosure involvesrestoring or otherwise improving blood flow in arterial vasculature,including, for example, the OA, by delivering a balloon or expandableelement to the OA, wherein said balloon is adapted and configured forplacement in the OA, and wherein said balloon is used to restore bloodflow in the OA. The expandable removal element may be movable between anexpanded position and a contracted position and may be utilized in asingle or multiple drive shaft configuration. Applicant notes thatreferences throughout the disclosure to the OA are exemplary, and thatin some embodiments, the devices, systems, and method described hereinmay be used to treat other arterial vasculature, such as vessels withsmall diameters and/or sharp-angled (e.g., tortuous) lumens.

The present disclosure also includes a medical device suitable fordelivery and deployment within the ophthalmic artery. The device may bevariously configured. The device may be a catheter comprising one ormore lumens. The lumens may be used to house, deliver, and/or retrieveone or more elements suitable for restoring blood flow in the ophthalmicartery, typically by removing a blockage or the like. Exemplary elementsinclude, but are not limited to, one or more guidewires, one or moreballoons, one or more blockage capture and retrieval elements, one ormore inflation elements (e.g., an inflation lumen), one or more filterelements, and/or one or more anchoring elements.

In some examples, the system for accessing the ophthalmic artery maycomprise a catheter, typically a catheter suitable for use inangioplasty or atherectomy procedures. The catheter may also be a guidecatheter.

In some examples, the medical device may include one or more lumens andelements as described above. In these arrangements, the medical devicemay not include a guide catheter.

The present disclosure also describes one or more devices comprising oneor more balloons for performing the methods described above.

In some examples, the device may comprise a cutter and/or captureelement for removing material from the ophthalmic artery. Some of theseexamples include a catheter and/or an aspiration lumen.

The present disclosure includes devices, methods, and systems forremoving, or restoring flow through, blockage or occlusive material in asmall diameter artery, such as the ophthalmic artery. The method mayinclude the steps of providing a catheter having a proximal end and adistal end; at least one guidewire configured to extend from or passthrough a distal tip of the catheter to a desired location; at least onelumen defining a channel within the catheter; and at least one balloonor expandable element configured for passing through a lumen of thecatheter and/or comprising a distal portion of a guidewire. As is wellknown to those skilled in the art, placing the catheter, guidewires, andballoons in a particular portion of the anatomy typically requires theuse of one of a variety of imaging techniques and devices, e.g.,fluoroscopy.

Restoring and/or increasing blood flow is used herein to refer to anydevice, method, therapy, or combination that changes the blood flow tothe eye. Examples of such include, but are not limited to increasing theblood flow anywhere in the vasculature leading to the eye or a portionof the eye; removing (e.g., atherectomy) or opening or displacing (e.g.,angioplasty) an obstruction in the fluid flow path in the vasculatureleading to the eye (e.g., from the ICA through the OA); delivering anddeploying a stent in the fluid flow path in the vasculature leading tothe eye; using atherectomy or similar devices to physically removeportions of any obstructions in the vasculature leading to the eye orportion of the eye; and localized drug and/or an oxygen device forincreasing flow or amount of oxygen in one or more eye tissues. In someexamples, a device or method of the present disclosure may be combinedwith a known or new drug or oxygen device in order to treat one or moreeye diseases or conditions.

The present disclosure may also include restoring and/or increasing theamount of nutrients that are available to one or more parts of the eyeor to the eye area, specifically by removing or partially opening ablockage in one or more of the arteries that supplies blood flow to theeye. In some examples, a blockage is removed or opened in the ICA, theOA, the ostium (as used herein, referring to the junction between theICA and the OA), or combinations thereof. To or near the eye, as usedherein, refers to the vasculature system that supplies blood to thevarious structures of the eye. As noted above, nutrients as used hereininclude, but are not limited to, oxygen, hemoglobin, complement, andglucose.

The present disclosure may also include methods, devices, and systemsfor removing or displacing a blockage in the ostium or a proximalsegment (e.g., short limb) of the OA near the ICA. In such arrangements,removing or displacing the blockage comprises opening a channel oraccess through the ostium sufficient to provide a therapeuticallybeneficial result to the eye, the rear of the eye, or portions thereof.In some arrangements, removing a blockage involves atherectomy devicesand methods. In some arrangements, opening or displacing a blockageinvolves angioplasty devices and methods. The present disclosure alsoincludes restoring and/or improving blood flow anywhere in the vascularpathway to or within the eye.

Therapeutically beneficial result is used herein to refer to anyperceived or actual benefit to the patient. Examples of beneficialresults may include but are not limited to: treatment of an eye disease,condition, and/or symptom; restoring or increasing blood flow in anymanner that treats an eye disease, condition, and/or symptom; andremoving or partially removing a blockage in the blood flow path betweenthe heart and the eye, in the OA or a portion thereof.

The present disclosure should not be limited solely to changing vascularflow in order to improve or restore the amount of nutrients that aredelivered to the eye. For example, in some examples, the vascular flowmay be unaffected for the most part, but the amount or concentration ofnutrients may be increased, thereby increasing the amount of nutrientsthat may be delivered to the eye or associated with the eye. One skilledin the art may recognize, with the teaching of this disclosure, thatthere are other biological systems or capabilities that may be used toincrease the amount of nutrients that are delivered to the eye.

In this and other aspects of the present disclosure, reducing or openinga blockage includes, but is not limited to, piercing or penetrating theblockage. In some examples, piercing and penetrating the blockage mayrefer to obtaining sufficient blood and/or fluid flow through or arounda blocked vascular area sufficient to provide a therapeuticallybeneficial amount of oxygen (or other such nutrient) to the eye or aportion of the eye.

There is provided in accordance with one aspect of the presentdisclosure, a method for removing, opening, displacing, or restoringflow through thromboembolic material from a small diameter artery, suchas the OA. Some methods involve using atherectomy devices and relatedprocedures; other methods involve using angioplasty devices and relatedprocedures. Still other methods include providing a catheter having aproximal end, a distal end, an expandable distal section having a distalport, an aspiration lumen communicating with the port, and an axiallymovable support. The method may include inserting the distal end of thecatheter into an artery of a subject, and distally advancing the supportto expand the distal section. Negative pressure is applied to theaspiration port, to draw the thromboembolic material into the distalsection.

In accordance with another aspect of the present disclosure, there isprovided an aspiration catheter. The catheter includes an elongateflexible tubular body, having a proximal end, a distal end, and anaspiration lumen extending therethrough. An aspiration lumen in a distalsection of the flexible tubular body is movable between a first, reducedinside diameter for transluminal navigation and a second, enlargedinside diameter for aspirating material.

Alternatively, a catheter of the present disclosure may include one ormore elements for physically capturing material and pulling it into thecatheter and/or washing it away from the site of the occlusion.

In other embodiments, a microcatheter is disclosed, having an outsidediameter of approximately 3-French or smaller, with the incorporation ofan outer, diametrically expansile/contractile element near the distalregion of the device. This expansile/contractile element coupled withthe microcatheter system can serve a variety of therapeutic indicationswithin the vasculature supplying blood flow or fluid flow to and fromthe eye. In some arrangements, the microcatheter can comprise adistention means for vascular anastomotic regions, flow restorationwithin an occluded vessel, foreign body retrieval, or an endovascularfilter.

In an embodiment, the microcatheter can comprise means to delivertherapeutic devices and diagnostic agents (e.g., TPA) through one ormore of the catheter's lumens or side holes, which further adds to thissystem's utility. The device's lumen, or lumens, could allow foraspiration and/or drainage.

Any of the devices, methods, embodiments, or variations of the presentdisclosure may be used with reverse flow or retrograde flow devices andmethods. An exemplary description of reverse flow devices and methodsincludes, but is not limited to PCT/US17/21673 (filed 9 Mar. 2017) andU.S. Pat. No. 9,259,215, both incorporated by reference herein in theirentireties.

A catheter or medical device of the present disclosure can be a tubularstructure with distal and proximal ends and at least one lumenthroughout its length or a portion of the catheter. The length of thecatheter may be determined by its access point into the body, e.g., atransfemoral approach or a cervical approach. The length of the catheterfor a transfemoral approach can be approximately 150 cm, and can rangefrom about 100 cm to about 200 cm. The catheter can have an outerdiameter with the diametrically expansile/contractile element contractedof no more than 1 mm (3 F). The length of the catheter for a cervicalapproach can be approximately 20 cm, and can range from about 10 cm toabout 30 cm. The microcatheter advantageously comprises lateralflexibility, which can be constant or can include a plurality ofincreasingly flexible regions moving from the proximal to the distal endof the microcatheter. The microcatheter includes columnar strengthsufficient to facilitate pushability/advanceability through thevasculature.

The outer diametrically expansile/contractile element, hereafterreferred to as the expandable element, which can be generally affixed tothe catheter shaft near the distal end of the microcatheter shaft, canbe fabricated from a variety of metallic or polymeric materials, eitherporous, non-porous, or a combination of these materials. This expandableelement can be located proximate the distal end of the micro-catheter.In other embodiments, the expandable element can be located flushagainst the distal end, or about 1-2 cm from the distal end to improveguidewire-aided navigation through tortuous vasculature. The design maybe provided with the expandable element having a maximum, expanded outerdiameter of about 0.5 mm to about 2.5 mm, or between about 1 mm andabout 2 mm.

Methods of Use

Other aspects or embodiments of the present disclosure include methodsof use. The catheter can be used to perform blockage retrieval, removal,displacement, or opening. In such an embodiment, the device may be firstprepared by flushing or priming the lumen with saline. The catheter isthen navigated to the site of the blockage. The catheter is advancedalong a guidewire so that the expandable element is positioned within orthrough the blockage. The expandable element is then expanded, engagingthe blockage. After engaging the blockage with the expandable element,the user can administer thrombolytic agents to further entwine or entrapthe blockage. The blockage may then be removed from the vasculature viathe catheter. Additionally, the user may elect to keep the expandableelement expanded, and remove the catheter device from the vasculature.Lastly, the blockage removal could be aided by aspiration through thecatheter side holes.

In other embodiments, the microcatheter can be used for the purposes ofanastomosis distension or dilation, vascular foreign body retrieval,temporary dilatation and flow restoration through atheromatous plaque,and vascular embolic filtering. These goals can be addressed byinserting the proper therapeutic device, such as a dilatation balloon,grasper or basket device, high force mesh dilator, or distal protectionfilter, respectively, through the working lumen of the microcatheter.

In accordance with some embodiments of the present disclosure, thecatheter and/or guidewire and/or balloon may be delivered or positionedat the proximal end of the OA by accessing the OA from a cranial orsuperior position. In some of these embodiments, the device may bepassed through the Circle of Willis or a portion thereof, or one or morecranial arteries, and approach the OA from a cranial or superiordirection in the ICA.

Balloons

In accordance with the present disclosure, the devices and methodsdescribed herein may include one or more elongation members, such as aballoon or inflatable member. These elongation members may be variouslyconfigured and may include multiple variations or alternatives. All ofthese configurations, variations, and alternatives are adapted andconfigured for delivery and/or placement in the OA, in the junction(e.g., ostium) between the ICA and the OA, and in the OA before thefirst bend (e.g., angle a) or turn (e.g., within the short limb of theOA).

An elongation member (as described further herein) or balloon of thepresent disclosure may be constructed of conventional materials; may bevariously shaped (e.g., tiered, dog-bone shaped, oval, elliptical, orround); may comprise a drug or chemical (e.g., may be drug-eluting)having therapeutic benefit or purpose; and/or may be compliant,semi-compliant, or non-compliant throughout the balloon or a portionthereof.

One embodiment of the elongation member is shown in FIGS. 1A and 1B. Inthis embodiment, a catheter/system 10 comprises a plurality of lumensincluding a first lumen 17 for housing, delivering, and deploying aballoon 14, a second lumen 11 for housing, delivering, and deploying aguidewire 12, and a third lumen 15 for delivering inflation fluid to theballoon 14 (e.g., via a distal end of balloon 14). The catheter alsoincludes an elongation member 13 having balloon 14 coupled thereto.Elongation member 13 may extend to a proximal end of the catheter formanipulation (e.g., proximal retraction and/or distal advancement) by amedical professional. As shown in FIG. 1A, the catheter/system 10 isadapted and configured for delivery and placement in the junction Jbetween the ICA I, and the OA O. That is, as shown, at least one or moreof guidewire 12 and balloon 14 may be routed through junction (e.g.,ostium) J and into a short limb S of OA O. Additionally, at least aportion of guidewire 12 may be advanced past angle A of OA O and into along limb LL of OA O. FIGS. 1C and 1D illustrate additional views of thecatheter of FIGS. 1A and 1B, having guidewire 12 removed therefrom. FIG.1C also shows a place of fluid communication 18 between inflation lumen15 and the distal end of the balloon 14. A side port in balloon 14 atits distal end may communicate with a side port in inflation lumen 15 ata place of fluid communication 18. In some embodiments, the inflationlumen 15 or inflated balloon 14 may sandwich or anchor the guidewirelumen 11 against the ostium O; in other embodiments the balloon 14 orinflation lumen 15 may sandwich or anchor the guidewire lumen 11 againstthe ostium O.

In this embodiment of the present disclosure, the configuration of theballoon 14, when inflated, sandwiches the guidewire 12, balloon 14,and/or lumen 11 in place, e.g., in the junction J between the ICA I andthe OA O. For example, inflation of balloon 14 may result insandwiching, pushing, or otherwise urging guidewire 12 into contact witha wall of the OA O. As such, the balloon 14 has sufficient complianceand/or flexibility to conform to the typical anatomy in this location.That is, the balloon 14 has sufficient compliance and/or flexibility soas to fill the short limb S of the OA O, thereby urging the guidewire 12into contact with the wall of the OA O. The anatomy between the ICA Iand the OA O includes the junction/ostium J, the short limb S, and angleA. The long limb is shown as LL. In this embodiment of the balloon 14,the balloon may be short, and does not watermelon seed out of place(e.g., slide away from its intended position in the junction between theICA I and the OA O). When the balloon 14 is inflated, it has the abilityto move with the anatomy. For example, inflation of balloon 14 mayinclude performing an angioplasty on the OA and, since the OA expandswith the inflated balloon 14, the OA is not dissected.

The elongation member 13 is preferably flexible (e.g., bendable),allowing the balloon 14 to move within the anatomy. Also, when theelongation member 13 is proximally retracted, a proximal end of theballoon 14 may be pulled in the proximal direction back into thecatheter while a distal end of the balloon 14 is fixed relative to theguidewire lumen 11 in any appropriate manner (e.g., via adhesive,crimping, etc.), thereby preventing the balloon from buckling within theanatomy. That is, proximal retraction of elongation member 13 by amedical professional may likewise proximally retract a proximal end ofballoon 14 relative to the distal end of balloon 14 which is fixed toinflation lumen 15. Accordingly, balloon 14 is stretched or elongateddue to the relative movement between elongation member 13 and inflationlumen 15. Typically, the elongation member 13 may be made from anelastic polymer, spring, corrugated tube, nitinol, a telescoping tube ortubes, or a fixed wire. Balloon 14 may be extruded over the elongationmember 13, thereby coupling the balloon 14 to the elongation member 13.In some arrangements, elongation member 13 includes a stretchablepolymer. Alternatively, elongate member 13 may include a rigid cable orwire.

In some arrangements, the elongation member 13 may extend distally of,or may stop near, a proximal waist of balloon 14.

Further, the balloon 14 can be inflated from the distal end or from theproximal end of the balloon 14.

Alternative designs are shown in FIGS. 2 and 3, which illustrateembodiments of the present disclosure in which the elongation member 13is attached to a two- or three-lumen shaft, respectively. In thisconfiguration, when the balloon 14 is inflated, an attachment (e.g., theelongation member 13) of the balloon 14 to the two- or three-lumen shaftat a proximal end of the balloon 14 stretches to match or conform to theanatomy In each of FIGS. 2 and 3, elongation element 13 may be arrangedas an elastic band/tube having one end coupled to balloon 14 and anopposite end coupled to the catheter/system 10 (e.g., coupled to theinflation lumen 15). As balloon 14 is inflated, elongation member 13 maystretch. Additionally, balloon 14 may be inflated through a distal endof balloon 14, as shown in FIG. 2. In other arrangements, however,balloon 14 may be inflated through a proximal end of balloon 14, asshown in FIG. 3. In such an arrangement, inflation lumen 15 maycommunicate with elongation member 13 which may be in communication witha proximal end of balloon 14. In this example, elongation member 13 maybe tubular so as to convey inflation fluid therethrough.

FIG. 4 illustrates a configuration in which a balloon 14A is offset orasymmetrical. In this embodiment, balloon 14A is inflated through thedistal end of balloon 14A via inflation lumen 15. For example, a distalwaist 19 of balloon 14A may be fluidly coupled with inflation lumen 15,as will be described in further detail below.

FIG. 5 illustrates a configuration in which the inflation lumen 15 isflexible (e.g., axially moveable relative to) at least one end of theballoon 14. In the illustrated embodiment, the lumen 15 includes aflexible element 20 (e.g., a spring, coil, etc.) attached to the shaftof the lumen 15 on both the proximal end and the distal end of theballoon 14. A first (e.g., proximal) end of each flexible element 20 maybe attached via any appropriate manner (e.g., adhesives, etc.) toinflation lumen 15 while a distal end of each flexible element 20 may beattached via any appropriate manner (e.g., adhesives, etc.) to balloon14. In such a manner, flexible elements 20 may permit or enable relativemovement between inflation lumen 15 and balloon 14. In some examples,each flexible element 20 may include a spring or coil that may extendand retract longitudinally. This embodiment shows a configuration forsandwiching or anchoring the guidewire 12 against a wall of an artery.

Arrangements of the present disclosure also may include a tip element 16(FIG. 5) attached to the distal end of the balloon 14 (or the distalflexible element 20), and includes a lumen to further position theguidewire 12. Tip element 16 may be attached via any appropriate mannerto one or more of a distal end of balloon 14, flexible element 20, andinflation lumen 15. Additionally, tip element 16 may include a passageor lumen through which guidewire 12 may be passed to direct advancementof balloon 14 relative to guidewire 12 or vice versa, or to maintainradial spacing between guidewire 12 and balloon 14.

In another embodiment of the catheter/balloon configuration, illustratedin FIGS. 6 and 7, the guidewire lumen 11 includes a guidewire 12 thatextends through a balloon 14. In the arrangement shown in FIGS. 6 and 7,guidewire 12 may act in the same manner as elongation member 13,described above. That is, in the arrangement of FIGS. 6 and 7, guidewire12 may be used to extend or retract balloon 14 relative to inflationlumen 15. As such, guidewire 12 may be fixed relative to balloon 14 inany appropriate manner. Additionally, inflation lumen 15 is coupled tothe distal end of the balloon 14. In such an arrangement, similar tothat described above in FIG. 1C, a channel, lumen, or communication 18may be provided between the distal end of balloon 14 and inflation lumen15. In this embodiment, the balloon 14 and/or guidewire 12 allows theballoon 14 to conform to the anatomy, and the balloon 14 may be inflatedfrom the distal end of the balloon 14. For example, during inflation,balloon 14 naturally wants to straighten. However, since the proximalend of balloon 14 is connected to flexible guidewire 12 and/orelongation member 13, the balloon is permitted to follow the trajectoryof the OA (or ostium) rather than straighten out. That is, since theproximal end of balloon 14 is permitted to move relative to a distal endof balloon 14, balloon 14 may conform to the anatomy of the OA and/orostium. In some embodiments, the guidewire 12 may be braided or coiledin a manner suitable for making the sharp turn or acute angle into theOA from the ICA.

In another embodiment, the catheter comprises a plurality of lumensincluding a first lumen 11 for housing a conventional guidewire 12 and asecond lumen 16 for housing a second guidewire 30 and a ball or balloon14B, as shown in FIG. 8. Additionally, the arrangement of FIG. 8 wouldinclude an inflation lumen 15 in fluid communication with balloon 14A.Guidewire lumen 11 may extend the length of the catheter and throughballoon 14A, the second lumen 16 may terminate at the first balloon 14Aand extend through an opening in balloon 14A. For example, second lumen16 may include a bend or turn that alters a direction of second lumen 16so as to direct second guidewire 30 and balloon 14B in a directionangled with respect to guidewire lumen 11. In use, balloon 14A may bedeployed in the ICA while second guidewire 30 and balloon 14B may extendthrough second lumen 16 to be positioned at the junction of the OA withthe ICA. In this embodiment, the second balloon 14B is shaped (orpre-shaped) and configured to fit into the OA ostium (e.g., junction J).When positioned in the ostium, the balloon 14B may then be inflated todilate the OA, to provide a stable base, and/or to prevent or reduceparticle generation. As such, the side branch (e.g., second branch)guidewire 30 and balloon 14B may directly access the OA (e.g., foraccessing and dilating the ostium junction J and/or short limb S). Thisembodiment also may include dual or multiple inflation lumens for theballoon(s).

The configuration shown in FIG. 8 also may include a perfusion featureor element, thereby allowing blood to flow through, past, or by theportion of the device in the ICA, as will be described in further detailbelow. The perfusion feature may be variously configured, including butnot limited to a separate channel or lumen through the device; a throughlumen on the side of balloon 14A; or grooves in the deployed balloon14B. These embodiments of the present disclosure may further include aguidewire/balloon diverter configured to position the OAguidewire/balloon 14B in the OA. In the embodiments of the presentdisclosure that include a perfusion structure or element, an example ofsuch a structure may be a side channel or pathway at or near the distalend of the balloon/lumen 14A positioned in the ICA. Other examplesinclude, but are not limited to one or more channels in a centralposition of the balloon/lumen 14A; or near the proximal end of theballoon/lumen 14A.

In another embodiment, the catheter, balloon, and or guidewire may bepre-shaped (e.g., including a bent distal end angled to facilitate entryinto the OA) to facilitate entry into the OA, as shown in FIG. 9A. Theballoon 14 may be shaped to match or conform to the ostium O. Forexample, the OA may have a funnel or cone-shaped cross-sectionalarrangement. That is, a diameter of the OA may vary along the length ofthe OA (e.g., may narrow such that a portion of the OA closer to theostium may have a cross-sectional dimension larger than a portion of theOA farther away from the ostium). As such, balloon 14 may be likewisetapered such that the shape of the balloon 14 is complimentary to theshape of the OA and/or ostium. In FIG. 9B, the catheter positions theballoon 14 and guidewire 12 into the OA. In FIG. 9C, the guidewire 12 isremoved or withdrawn, and in FIG. 9D, the balloon is inflated in theostium. Once inflation is complete, the balloon 14 and guiding catheter10 may be removed or withdrawn. In this embodiment, the balloon 14 maybe designed to slip out of the anatomy or to be held in a staticposition during dilatation. For example, under pressure, the balloon 14may displace from the OA short limb to the ICA (e.g., “watermelonseeding”).

The balloon 14 and/or inflation lumen 15 may be pre-formed and shaped toconform to the anatomy at the junction J of the OA and the ICA, whereinthe guiding or delivery catheter 10 straightens the balloon 14 and/orinflation lumen 15 during delivery and, when the catheter is withdrawnor the balloon 14 is pushed out of the catheter, its release therebyallows the balloon 14 and/or inflation lumen 15 to assume its pre-formed(angled) shape. That is, when positioned radially within guidingcatheter 10, inflation lumen 15 and balloon 14 generally may extendalong an axis extending through guiding catheter 10. Upon retraction ofguiding catheter 10 relative to inflation lumen 15 and balloon 14,inflation lumen 15 and balloon 14 may deflect away from such an axis soas to form an acute bend arranged to facilitate entry into the OA. Insome arrangements, one or both of inflation lumen 15 and balloon 14 mayinclude a shape memory material (e.g., Nitinol) to facilitate bending ordeflecting thereof.

In another embodiment, the catheter may include a dilatation balloon 14Aand an anchor balloon 14B, positioned on one (e.g., the same) or more(e.g., different) guidewires. An illustration of this embodiment isshown in FIGS. 10A-10C in which inflation lumen 15 may include anextruded polymer tube or the like over a guidewire (e.g., a “balloon ona wire”). In this embodiment, the dilatation balloon 14A is shaped toconform to the OA (e.g., is sized such that upon expansion, dilatationballoon 14A contacts a wall of the OA), more specifically, the ostiumjunction J. In FIG. 10A, the dilatation balloon is positioned in thejunction between the ICA and the OA and anchor balloon 14B remainsuninflated. In FIG. 10B, the anchor balloon 14B is inflated, and thenthe dilatation balloon 14A is inflated. The anchor balloon 14B preventsthe dilatation balloon from backing out from the ostium junction J intothe ICA I. FIG. 10C shows an embodiment in which a balloon catheter isinside a guiding catheter 10, thereby anchoring balloon 14B to guidecatheter 10 rather than a wall of the ICA.

In another embodiment, the balloon and/or the guidewire may include abias in one direction to conform the element(s) to the anatomy of theICA and OA junction J. In preferred embodiments, the balloon andoptionally the guidewire 12 are biased toward a deflected configuration.An example is shown in FIG. 11A-11C in which, as opposed to thearrangement of FIGS. 10A-10C where balloon 14 was coupled to inflationlumen, balloon 14 of FIGS. 11A-11C is coupled directly to guidewire 12.FIG. 11A shows an uninflated balloon 14 on a guidewire 12 designed toconform or fit into the ICA/OA ostium. During and after inflation, thebias in one direction allows the balloon 14 to conform to the angle ofthe junction J between the ICA and the OA (FIGS. 11B-11D) That is, thebias deflects one or more portions of balloon 14 and/or guidewire 12 ator along an angle (e.g., an acute angle) so as to enter the ostiumjunction J and/or OA O. The arrangement may be biased in any appropriatemanner. For example, guidewire 12 may be pre-shaped to include a curveor bend. Additionally or alternatively, balloon 14 may be fabricatedsuch that it is shorter on one side than the other, thus resulting in abiased or deflected arrangement upon inflation. In this embodiment, thebias is intended to prevent or reduce vessel straightening. That is, theshort arm of the OA typically connects with the ICA at an angle. Inparticular, the connection may be curved. Biasing the balloon and/orguidewire may enable the balloon 14 and/or guidewire 12 to fit withinthis angled and curved structure without forcing the short limb of theOA to adjust the angle at which it extends from the ICA. In alternativeembodiments, the bias may be in the guidewire alone, and may not includethe balloon. Embodiments having a biased guidewire and/or balloon mayfurther include a delivery or guiding catheter, or may not.

In another embodiment, the balloon is designed to fit or conform to theanatomy of the OA and/or the ostium by varying the point(s) ofattachment to the catheter or guidewire. This fit or conformance in theostium is intended to keep the distal portion of the balloon within theshort arm of the OA such that when inflated, vessel straightening doesnot occur beyond the distal portion of the short limb of the OA. In aconventional arrangement, the balloon 14 is attached to the guidewire atboth the distal and proximal ends of the balloon 14, as shown in FIG.12A. In accordance with the present disclosure, the balloon 14 may beattached at the proximal end, but the distal attachment point may becloser to the center of the balloon 14 so as to cause portions ofballoon 14 to overlap and/or invert on itself, thereby providing adiscrete distal edge of the balloon 14 which substantially matches thedistal anatomy of the short limb of the OA. As such, this distal edge ofthe balloon 14 will not extend past the distal most portion of the shortlimb. The distal attachment point may be varied along the body of thecatheter or guidewire during device fabrication to provide adjustment ofoverall device flexibility. Two examples are shown in FIGS. 12B and 12C,in which the second attachment point is more proximal along the lengthof the balloon 14 than the distal end of balloon 14. In other words, thedistal attachment between the balloon and the guidewire may be spacedproximally from a distal end of the balloon 14. In these embodiments,the distal attachment point allows a distal end of the balloon 14 tofold when the balloon is deflated so that the tip of the guidewire ismore flexible. In a further embodiment, such attachment points may bedesigned to impart vessel straightening of the OA. FIG. 12 D shows aballoon 14 with an attachment point (e.g., a heat joint, adhesives,etc.) to a guidewire at the proximal end and a second attachment pointat any point proximal of the distal end of balloon 14. As shown, theballoon 14 may fold of conform to the anatomy of the OA and/or theostium. In some of these embodiments (not illustrated), a distal end ofguidewire 12 may be flush with the distal end of the balloon. In otherarrangements, a distal end of the guidewire 12 may extend distally of adistal end of the balloon.

The embodiments shown in FIGS. 12A-12D may be an over-the-wireconfiguration or a fixed wire configuration.

FIGS. 13 A-C show a guidewire 12 and distal balloon 14 configurationwherein the uninflated OA balloon 14 may be inserted into proximal endof the OA, e.g., at the ostium junction J. In this embodiment, theoperation of which is described in more detail below, the compliant orsemi-compliant balloon 14 may be placed in the OA, then inflated orpartially inflated which forces the balloon out of the OA and into theICA.

In another embodiment, a system comprises a first guidewire 12configured for delivery and placement in the ICA adjacent the OA. Asshown in FIG. 14A, this guidewire may include a first balloon, or in theillustrated embodiment, may include a bifurcated balloon 14B. Thebifurcated balloon 14B may be configured so a first portion is adaptedfor placement in the ICA distal to the OA and a second portion isadapted for placement at the junction of the OA or just proximal of thejunction of the OA. Bifurcated balloon 14B may have a narrowed orthinned portion in communication with the distal portion and theproximal portion which may enable additional flexibility to bifurcatedballoon 14B The system further comprises a second guidewire 30 suitablefor placement and entry into the OA O. The second guidewire 30 comprisesa second balloon 14C configured and adapted for placement in theproximal end of the OA.

As shown in FIG. 14B, a single (e.g., non-bifurcated) balloon 14 may beused for the ICA balloon. In some embodiments, balloon 14 may includezones or sections of different compliancy. In some embodiments, balloon14 may be compliant near the waist portion (e.g., FIG. 14A). Typically,a balloon in the ICA (or any structure not needing dilation) iscompliant. A balloon (or balloon portion) 14C in the OA may besemi-compliant or non-compliant, and may or may not be inflated to apre-determined and/or set pressure or size.

In another embodiment, shown in FIG. 14C, a first balloon 14 is notbifurcated, and is adapted for placement near but not over (e.g., distalof or downstream of) the entrance (e.g., the junction J or ostium) tothe OA O, and the second guidewire 12 and second balloon 14C stem fromthe system or a second lumen of the system orthogonally or angled withrespect to the first guidewire and first balloon.

In all of the embodiments shown in FIGS. 14A-C, the first balloon 14,14B, helps stabilize the second balloon 14C when the second balloon 14Cis inflated, keeping the second balloon 14C from watermelon seeding outof (or otherwise slipping out of) the OA upon inflation. In each ofthese embodiments, the balloons can be over-the-wire, rapid exchange, orfixed wire configurations.

In an embodiment, the system may include an inflation lumen 15 and aseparate guidewire lumen 11. Two examples of such configurations areillustrated in FIGS. 15A and 15B. For example, FIG. 15A illustrates aninflation lumen coupled to a proximal end of a balloon, while FIG. 15Billustrates an inflation lumen extending through the balloon and coupledto a distal end thereof. Due to the inclusion of inflation lumen 15extending through the balloon, the balloon of FIG. 15B may have a largerouter profile/dimension than the balloon of FIG. 15A

In a method according to the present disclosure, the balloon may beintentionally underinflated. For example, a 2 mm diameter balloon (e.g.,a balloon having a maximum inflated diameter of 2 mm) is inflated toproduce only 1.25 or 1.50 mm diameter dilatation. The balloon isselected based on the desired dilatation outcome, e.g., larger than thediameter of the target anatomy. In these methods, the balloon, wheninflated, intentionally slides out of the target anatomy (e.g., the OA).For example, a larger than required balloon may not be supportedcircumferentially in the ICA, and as such, the balloon may be free towatermelon seed out of the OA and into the ICA.

The balloon 14 may be partially inserted into the target anatomy (e.g.,the OA). In some embodiments, only the distal ⅓ of the balloon 14 isinserted into the area of dilatation. The balloon 14 is then inflated atthe lower end of its inflation capacity (e.g., about 6 to 8 ATMS). Asthe balloon 14 is inflated, the larger diametric area of the balloon(larger as compared to the ID of the target anatomy) will force theballoon 14 to slide out of the target anatomy and into the adjacentanatomy, e.g., slide from the ostium or OA and into the ICA in aretrograde manner or otherwise in a direction opposite that of antegradeblood flow.

In accordance with the present disclosure, the intentional use of thewatermelon seed affect has a therapeutic effect: it opens or clears theostium of any blockage or material covering the ostium.

The method used in this Example is illustrated in FIGS. 13 A-C. In FIG.13A, a 2 mm diameter semi-compliant balloon (6 mm length) is insertedinto the ostium of the OA, an area of the anatomy that is typicallyabout 1 mm or less in diameter. In FIG. 13B, when the balloon isinflated to less than its nominal inflation pressure, the balloon isforced out of the OA into the ICA in a “watermelon seed” phenomenon.That is, if the balloon is inflated to a pressure less than that of thenominal pressure, the balloon may begin to exit the anatomy at lowpressures. In FIG. 13C, the balloon completely exits the OA and entersthe ICA, but in accordance with this method, partial dilatation of theostium occurs, clearing any blockage in the ostium and the OA.

In the designs of the present disclosure, it may be desirable to coatthe outside surface of the guidewire 12, the catheter body/system,and/or the balloon 14, 14A, 14B, 14C, and/or the inside surface of thewall defining a lumen of the catheter. Typically, these coatings arelubricious to minimize friction. A variety of coatings may be used,including but not limited to Parylene, Teflon, silicone rubber,polyimide-polytetrafluoroethylene composite materials, as well as othercoatings known in the art.

Alternatively, the coating may be tacky, sticky, or include bumps orappendages specifically designed to hold or retain one or more elementsin place or to otherwise inhibit movement of the one or more elementsrelative to the coating.

In another embodiment, a system may include one or more lumens and oneor more guidewires. In some embodiments of the present disclosure theguidewire lumen may be sandwiched against the wall of an artery. Inother embodiments of the present disclosure, the guidewire may besandwiched against the wall of an artery.

In another embodiment, devices, systems, and methods may be used toaddress a site-specific blockage B in the OA, specifically in the ostiumand/or the short limb S. For example, as opposed to other arrangementsdisclosed herein which may be used to treat a variety of anatomicallocations (e.g., the OA, the ICA, the ostium, a carotid artery, or thelike), further arrangements according to the present disclosure may berestricted for use in a particular anatomical location. A typicallocation of such blockages is shown in FIGS. 16A and 16B. FIG. 16Cillustrates an embodiment in which a cutting catheter includes a cutterwindow and a cutting element adapted for communicating with the debrisor blockage. Exemplary cutters include but are not limited to a pullbackcutter, a push cutter, and a rotational cutter. A balloon 14B is shownin an exemplary position distal to the cutting window and the blockageB, and is configured and adapted for placement in the ostium or shortlimb S of the OA O.

An alternative configuration is shown in FIG. 16D, in which a balloon14C is positioned adjacent the cutting element, and when inflated, theballoon anchors the cutter and pushes the cutter into the debris orblockage B.

In the embodiments shown is FIGS. 16C and 16D, the balloon(s) 14B, 14Cblock any debris from moving distally into the OA O, and aspiration maybe used to remove the debris and/or occlusive material. Also, the sideof the OA O in this location of the OA O may be used to place the cutterwindow within the blockage B or occlusive material. As noted above, theballoon 14B, 14C may be used to anchor the cutter, and it can also beused to push the cutter into the occlusive material or blockage B. Forexample, inflation of the balloon 14B, 14C may deflect or otherwise urgethe cutter window towards the blockage B.

FIG. 17 illustrates an embodiment in which the system includes aperfusion feature, thereby allowing blood to flow past the ICA portionof the device (e.g., past balloon 14A inflated in ICA I). In theillustrated embodiment, blood flow is maintained (as illustrated byarrows 2) during the ICA balloon 14A inflation. In accordance with thepresent disclosure, any structure or configuration that allows blood topass by the ICA portion of the system may be used, including but notlimited to, a blood flow channel or lumen; grooves or channels in theICA balloon 14A, one or more bypass channels or structures, andcombinations thereof. In use, balloon 14A may be delivered over a firstguidewire 12 arranged within inflation lumen 15B, while balloon 14B maybe delivered over a second guidewire 12 arranged within inflation lumen15A. Balloon 14A may have any appropriate shape including a channel toallow blood to perfuse therethrough.

This embodiment also shows two inflation lumens 15A and 15B. In thisembodiment, inflation lumen 15B anchors or positions inflation lumen 15Ain place, thereby anchoring the OA dilatation balloon 14B in the OA O.

Allowing blood to flow past the ICA portion of the device (e.g., pastballoon 14A as shown by arrow 2) makes this embodiment particularly wellsuited for use with reverse or retrograde flow systems. For example, inarrangements in which the ICA is blocked thereby inducing reverse bloodflow in the ICA, the perfusion lumen may be arranged to deliver blood ina retrograde or reverse direction (e.g., in the direction opposite thearrows 2).

FIG. 18 shows an alternative configuration that allows blood to flowpast a portion of the device in the ICA (e.g., past balloon 14A). FIG.18 illustrates an embodiment in which a catheter 10 includes at leastone lumen 15C or channel within the catheter for allowing blood to passthrough the ICA I (e.g., a perfusion lumen within which a guidewire 12may extend). The illustrated embodiment also shows balloon 14A anchoringor positioning the lumen 15C in place. That is, inflation of balloon 14Ain catheter 10 may deflect, urge, or otherwise push lumen 15C intoengagement with a wall of catheter 10 to prevent movement of lumen 15Crelative to catheter 10, which may prevent the balloon from watermelonseeding out the OA and into the ICA.

FIGS. 19 and 20 show an embodiment in which an OA portion of the deviceis configured sized, and/or shaped in a manner complimentary to thespecific anatomy in the junction J between the ICA and the OA. In theillustrated embodiment, the OA portion of the device is hinged 18,articulatable, or movable in relation to an ICA portion of the device.The hinge 18 (or an articulation lumen) also anchors or supports the OAportion of the device in place in the OA.

The illustrated configuration may include an open and/or close mechanismor element for releasing the OA portion of the device (FIG. 19) orclosing the OA portion of the device (FIG. 20). For example, a wire 19,loop, spring, or the like may be arranged about the OA portion device.For example, the device may include a lumen 15D though which wire 19having a wire loop at a distal end thereof extends. The wire loop ofwire 15 may surround the OA portion of the device and upon extension orloosening of the loop or wire 19, the OA portion of the device maydeflect radially outwards away from the ICA portion of the device, asshown in FIG. 19. Upon retraction or tightening of the loop or wire 19,the OA portion of the device may deflect radially inwards toward the ICAportion of the device, as shown in FIG. 20.

In this embodiment, the device is adapted for delivery and removal fromthe ICA and OA. The device may be positioned in the ICA in its closedposition (FIG. 20) above, superior, distal, or downstream to the OA.Next, the OA portion may be released, thereby facilitating entry intothe OA (FIG. 19). Additionally, the device may be withdrawn from itsposition in the ICA by pulling the OA portion flush against the ICAportion of the device.

FIG. 21 shows an embodiment of the present disclosure comprising aballoon 14C configured and adapted for deployment or positioning in thelong limb LL of the OA. In this embodiment, the device may include atleast one balloon, and in the illustrated embodiment, three balloons. Inthe illustrated embodiment, balloon 14B anchors, stabilizes, or supportsballoon 14C in place in the LL of the OA, and balloon 14A anchors,stabilizes, or supports balloon 14B in place in the short limb S orostium junction J of the OA.

This configuration also illustrates the use of multiple balloons ofdifferent compliancy, e.g., balloon 14B is preferably compliant,non-compliant, or semi-compliant; balloon 14C is preferably compliant.

FIG. 22 shows an alternative configuration of a catheter having an OAlumen configured for deployment in the OA and adapted for the acuteangle between the ICA and the OA. In the illustrated embodiment, the OAlumen and balloon may be deployed in the OA by first wrapping the OAportion around the ICA portion of the catheter and angling the OAportion down into the OA. This figure also illustrates anotherembodiment of the present disclosure, in which a lumen may be largeenough to guide both the guidewire and the balloon. In the illustratedembodiment, guide catheter 51 is configured for positioning in the ICA.A balloon 14B and guidewire lumen 15A extend from a portion (e.g., adistal end) of the guide catheter 51, and loops around (e.g., behind)the guide catheter 51 and enters the OA from the superior or cranialside. In the illustrated embodiment, balloon 14B and guidewire lumen 15Aare sized to position both a guidewire lumen and a balloon lumen, andconfigured to enter the OA. In some embodiments, balloon and guidewirelumens may be positioned in a tube or the like, which can in turn beheat shrunk to the desired size around the lumens. Additionally, FIG. 22illustrates an arrangement in which balloon 14B includes a pair ofattachment points for coupling balloon 14B to lumen 15A. As shown, thedistal attachment point of the balloon 14B is provided proximally of thedistal end of the balloon 14B.

The various embodiments of the present disclosure provide a number ofconstructions of expandable vascular material removal and/or openingdevices, intravascular material removal and/or opening elements, and thelike, which can be utilized to perform a plurality of differentintravascular treatments, such as atherectomy, thrombectomy, angioplastyand the like. The embodiments of the present disclosure also provide aplurality of methods for using those devices and their associatedvascular material removal or opening elements for performingintravascular treatments on a patient. It is to be fully recognized thatthe different teachings of the embodiments, examples, and arrangementsdisclosed herein can be employed separately or in any suitablecombination to produce desired results. The embodiments provide, in theform of expandable intravascular removal or opening elements, ways ofchanging cutting or removing profiles, configurations or characteristicsof a particular intravascular treatment device while only using a singleremoval or opening element. An inner hollow tube or sheath is locatedbetween an inner, proximal end of the housing. The inner sheath definesa lumen of dimensions sufficient for accepting a medical guidewire, madeof stainless steel, nitinol, and the like, which can extend from theguidewire lumen within the inner sheath, and through an aperture in theproximal end of the housing to the exterior of the housing.

The hollow shaft also defines a guidewire lumen, thereby allowing forpassage of the guidewire from the material removal element to theexterior of the housing. Thus, the removal device 10 is of anover-the-wire construction which can facilitate removing the devicefrom, and replacing the device in the patient because the guidewire canremain within the patient. Comparatively, some prior art devices requireremoval of the guidewire along with the device, thereby necessitatingadditional intravascular navigation not only of the device, but also ofthe guidewire to replace the device adjacent the occlusion material tobe removed. In addition, the presence of the guidewire facilitatesintravascular navigation of the removal device, because the device canbe delivered over the guidewire, which is an improvement over someexpandable intravascular devices.

While an expandable intravascular removal or opening element is highlydesirable for the reasons discussed earlier, it may be desirable tolimit the maximum size of these intravascular elements. It may bedesirable not to over-expand the expandable elements. While some meansfor positively limiting radial expansion of the expandable intravascularelement have been detailed hereinabove, it may be desirable to provideadditional safety mechanisms.

The removal or opening device may include a manifold assembly and acatheter assembly. Specifically, the manifold assembly includes a thirdport located distally of the port. The port may be connectable with asuitable source of fluid, not shown, but known in the art, for supplyingthe catheter assembly with fluid to dilate a dilating member forperforming balloon angioplasty. The port may be located distally of aproximal end of the catheter assembly.

A dilating member, constructed substantially similarly to an angioplastyballoon, is located on the catheter assembly offset proximally of adistal end of the catheter assembly and the distal end of the driveshaft lumen. The inflation lumen extends from the port to a proximal endof the dilating member and conveys fluid from the fluid source,conventionally referred to as an inflation device, to and from thedilating member, thereby causing the dilating member to inflate anddeflate. To facilitate intravascular location of the dilating member, aradiopaque marker band is provided on the outer surface of the driveshaft lumen, thereby rendering the intravascular portion of the dilatingmember radioscopically visible to a treating physician. Intravascularinflation of the dilating member provides added stability to the distalportion of the removal device during operation thereof, while alsoallowing the treating physician to occlude blood flow through thevascular lumen being treated and further allowing the physician toperform balloon angioplasty if desired. With the removal device it ispossible for a treating physician to cut, remove, and/orangioplastically displace vascular occlusion material while only using asingle piece of equipment.

Examples:

In a first cadaver lab experiment, a PTCA balloon was placed into the OAvia the ICA in-situ, and inflated in the segment of the OA (e.g., theshort limb S) proximal to the first sharp bend (e.g., angle A). In asecond cadaver lab experiment, a PTCA balloon was placed and inflated inthe target area ex-vivo, in the OA ostium. This experiment was repeatedtwo times.

In both experiments, the balloon was successfully placed in the targetarea and dilated, without causing any apparent damage to the OA or theostium.

The balloons used in the first experiment had a maximum inflateddiameter of 0.8 mm at 16 ATMs. The working length was 3.5 mm. Theballoon used in the second experiment had a maximum inflated diameter of2.0 mm at 8 ATMs. The working length was 6.0 mm.

The in-situ experiment (e.g., first experiment) demonstrates that theballoon is capable of navigating the ICA anatomy, can be positioned inthe short limb of the OA (before the first sharp bend in the OA), andinflated without causing any apparent damage to any of the vessels.

The ex vivo experiment (e.g., the second experiment) demonstrates thatthe balloon can be visualized in the correct location in the proximalend of the OA and can be oversized and inflated without causing damageto the OA or ostium.

These two experiments show that it would be possible to navigate andinflate a balloon catheter within the target anatomy of a living patientvia an endovascular approach. These experiments also show that it ispossible to precisely size a balloon catheter to the OA anatomy, oroversize a balloon catheter to the OA anatomy and dilate without causingdamage to the anatomy.

In some aspects, accessing the OA or other anatomical locations may bedifficult. For example, in guiding a medical device (e.g., a catheter,guidewire, etc.) to the OA, the medical device may be required totraverse tortuous anatomy requiring a number of sharp angled bends ordirection changes. Indeed, to access the OA via the connected carotidartery via an inferior approach, the medical device may be required tobend at an acute angle. An alternative approach may be to access the OAfrom a cranial, upper, or superior position. That is, approaching the OAfrom a superior position may require advancing the medical device alonga less tortuous path. As such, a medical device may more easily beintroduced to the OA via the superior approach, which may result inreduced procedure time, reduced procedure cost, and reduced risk ofdamaging or rupturing an arterial structure or other tissues.

In accordance with exemplary methods of this disclosure, therefore, oneor more devices may be delivered to, or introduced within, an identifiedanatomical location via the Circle of Willis, for example, by firsttraversing all or part of the Circle of Willis and approaching a targetartery from a superior position. For example, in some arrangements, amedical device such as a catheter or guidewire 500 may be tracked (e.g.,guided, steered, and/or passed) through either the left or right ICA,around a portion of the Circle of Willis (e.g., through the anteriorcommunicating artery) into the other of the left or right ICA, andtowards the OA. In such a manner, the guidewire wire 500 may approachthe OA from an upper or superior direction so as to better align withthe trajectory of the OA and reduce a tortuosity of the path throughwith the medical device may be passed.

For example, as shown in FIG. 23, guidewire 500 may be advanced througha vertebral artery, enter a posterior communicating artery of the Circleof Willis, through the right ICA, around a portion of the Circle ofWillis superior to the ICA (e.g., the anterior communicating artery),into the left ICA, and into a target OA from a superior direction. Thetarget OA may include a blockage (e.g., a complete or partial blockage)therein to be treated via any of the methods and devices described inthis disclosure.

In additional arrangements, guidewire 500 may be tracked from aninferior direction (e.g., guided, steered, and/or passed) through atarget ICA (e.g., the left ICA), around a portion of the Circle ofWillis (e.g., via communicating arteries), and back into the target ICA(e.g., the left ICA) so as to approach the OA from an upper or superiordirection.

In some arrangements, a percutaneous interventional device (e.g., acatheter and/or guidewire 500) may be advanced into the Circle of Willisfrom an inferior position and directed toward or into one or morearteries of the Circle of Willis. The one or more arteries may includethe anterior cerebral arteries, the internal carotid arteries, branchesof the internal carotid arteries, the vertebral arteries, the anteriorcommunicating arteries, the posterior cerebral arteries, the basilararteries, branches of the basilar arteries, and the posteriorcommunicating arteries. Next, the percutaneous interventional device maybe directed into the ICA and into a target OA from a superior position.

One skilled in the art will recognize that the present disclosure asdescribed here may be reconfigured into different combinations,elements, and processes which are included within the scope of thepresent disclosure.

While the present disclosure has been described in some detail by way ofillustration and example, it should be understood that the presentdisclosure is susceptible to various modifications and alternativeforms, and is not restricted to the specific embodiments set forth inthe Examples. It should be understood that these specific embodimentsare not intended to limit the present disclosure but, on the contrary,the intention is to cover all modifications, equivalents, andalternatives falling within the spirit and scope of the presentdisclosure.

We claim:
 1. A method for treating tissue of at least one of an internalcarotid artery, an ophthalmic artery, or an ostium between the internalcarotid artery and the ophthalmic artery of a subject, the methodincluding: expanding a first expandable device of a first device in theinternal carotid artery; delivering a second device into the ophthalmicartery via the first device and expanding a second expandable device ofthe second device in the ophthalmic artery; and adjusting an angle ofthe second expandable device relative to an axis of the first devicefrom a first angle to a second angle different than the first angle,wherein, upon adjusting the angle of the second expandable devicerelative to the axis of the first device, the first expandable device isdistal of the second expandable device.
 2. The method of claim 1,wherein adjusting an angle of the second expandable device relative tothe axis of the first device includes pivoting the second devicerelative to the first device via a hinge.
 3. The method of claim 2,wherein pivoting the second device relative to the first device includesproximally tightening a loop around the second device.
 4. The method ofclaim 2, wherein the hinge includes a spring.
 5. The method of claim 1,wherein adjusting an angle of the second expandable device relative tothe axis of the first device includes tightening a loop around thesecond device.
 6. The method of claim 1, further including returning,after the adjusting an angle of the second expandable device relative tothe axis of the first device, the second expandable device from thesecond angle to the first angle.
 7. The method of claim 1, furtherincluding: removing the first device and the second device from thesubject.
 8. A method for treating tissue of at least one of an internalcarotid artery, an ophthalmic artery, or an ostium between the internalcarotid artery and the ophthalmic artery of a subject, the methodincluding: delivering a first device having a first expandable device ata distal end thereof within the internal carotid artery, and expandingthe first expandable device therein; delivering a second device having asecond expandable device at a distal end thereof, within the ophthalmicartery, and expanding the second expandable device therein, wherein thesecond device is coupled to the first device via a hinge positionedupstream of the second expandable device; and manipulating a wire so asto adjust an angle of the second expandable device, relative to an axisof the first device, from a first angle to a second angle different thanthe first angle, wherein, upon adjusting the angle of the secondexpandable device relative to the axis of the first device, the firstexpandable device is distal of the second expandable device.
 9. Themethod of claim 8, wherein the wire includes a distal loop, and whereinmanipulating the wire includes at least one of tensioning or looseningthe distal loop.
 10. The method of claim 9, wherein the distal loop islooped around at least a portion of the second device.
 11. The method ofclaim 10, wherein the at least the portion of the second device isupstream of the second expandable device.
 12. The method of claim 9,wherein manipulating the wire so as to adjust the angle of the secondexpandable device, relative to the axis of the first device, from thefirst angle to the second angle, includes tensioning the distal loop.13. The method of claim 12, further including loosening the distal loop,so as to adjust the angle of the second expandable device, relative tothe axis of the first device, from the second angle to the first angle.14. The method of claim 8, wherein the hinge includes a spring.
 15. Amethod for treating tissue of at least one of an internal carotidartery, an ophthalmic artery, or an ostium between the internal carotidartery and the ophthalmic artery of a subject, the method including:delivering a device in a collapsed configuration to a location withinthe internal carotid artery, wherein, in the collapsed configuration, afirst lumen of a first portion of the device is positioned alongside asecond portion of the device; releasing the second portion of the devicerelative to the first portion of the device and inserting the secondportion of the device within the ophthalmic artery; and manipulating awire so as to adjust an angle of the second portion of the device,relative to an axis of the first portion of the device, from a firstangle to a second angle different than the first angle, wherein, uponadjusting the angle of the second portion of the device relative to theaxis of the first portion of the device, the first portion of the deviceis distal of the second portion of the device.
 16. The method of claim15, further including: expanding a first expandable device of the firstportion of the device within the internal carotid artery.
 17. The methodof claim 16, further including: expanding a second expandable device ofthe second portion of the device within the ophthalmic artery.
 18. Themethod of claim 15, wherein the wire includes a distal loop, and whereinmanipulating the wire includes at least one of tensioning or looseningthe distal loop.
 19. The method of claim 18, wherein the distal loop islooped around the second portion of the device.
 20. The method of claim19, wherein the distal loop is positioned upstream of the second portionof the device.